FS-LASIK Surgery Effect on Higher Order AberrationsNCT04966806
Contribution of SA and Coma to The Total Ocular HOA Before and After FS-LASIK Using An Aspheric Ablation Profile
A study testing LASIK refractive surgery in people with FS-LASIK Surgery Effect on Higher Order Aberrations, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Laser-assisted in situ keratomileusis (LASIK) is the most frequently performed refractive surgery procedure for the correction of myopia, hyperopia, and astigmatism. There is a continuous upgrade and development in LVC surgeries correlated with the evolution of new machines and enhancement of the ablation profiles. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- FS-LASIK Surgery Effect on Higher Order Aberrations
- What is being tested?
- LASIK refractive surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2021to 15 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: between 18 years and 45 years
- Myopes from -1.50 D to -8.00 D
- Astigmatism less than -4.00 D
- Normal Corneal Tomography with a Belin Ambrosio big D value of less than 1.6
Who cannot join
- Unstable refraction for 1 year
- Corneal thickness less than 500 microns
- Expected Post Lasik Residual Stromal bed less than 300 microns
- All patients with post operative complications as epithelial overgrowth or decentered ablation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contribution of Spherical Aberration and Coma to The Total Ocular High Order Aberration Before and After Femtosecond Laser-Assisted in Situ Keratomileusis Using An Aspheric Ablation Profile
Laser-assisted in situ keratomileusis (LASIK) is the most frequently performed refractive surgery procedure for the correction of myopia, hyperopia, and astigmatism.
There is a continuous upgrade and development in LVC surgeries correlated with the evolution of new machines and enhancement of the ablation profiles. One of the main undesirable effects of corneal refractive surgeries using conventional ablation profiles is the increase in HOAs which is associated with haloes, glare, ghost images, starburst patterns and monocular diplopia, especially in low lighting conditions and during night driving.
Read more
Over the years many ablation profiles have been developed such as wavefront-guided, wavefront optimized, topography guided, Q- Value based and aspheric ablation profiles. These profiles aim to abolish LOAs and to prevent induction or increase of pre-existing HOAs aiming to improve the quality of vision experienced post-operative.
In spite of the vast body of research in this area, there remains a gap in the literature investigating higher-order aberrations' components in-depth. Therefore, this study aims to investigate the contribution of spherical aberration and coma to the total higher order aberration before and after femtosecond assisted laser in situ keratomileusis using an aspheric ablation profile.
This current study is a Descriptive analytical study that was conducted on 34 eyes of 17 patients who underwent corneal refractive surgery.
The results were analyzed to compare the effect of FS-LASIK surgery on corneal coma and SA, and the contribution of each of them on total ocular HOAs preoperative and post-operative.
- Being tested
- LASIK refractive surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASIK refractive surgeryProcedure or surgery
laser vision correction for myopic eyes
| Study group | Role | What they receive |
|---|---|---|
| Percentage of Coma and SA to Total ocular HOA | Other | Not described Receives: Procedure: LASIK refractive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percentage of contribution of coma and spherical aberration from total ocular HOA before and after FS-LASIK.
Measuring unit for coma and spherical aberrations and total ocular HOA is equivalent Diopters.
The contribution of coma and spherical aberrations to total ocular HOA will be measured as a percentage.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start10 Jul 2021 (estimated)
- Primary completion15 Oct 2021 (estimated)
- Study completion15 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FS-LASIK Surgery Effect on Higher Order AberrationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Sameh Youssef, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966806
- Sponsor's protocol ID
- PSYoussef
- Status last verified
- Jul 2021
- First submitted
- 25 Jun 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Spherical Aberration and Coma to The Total Ocular High Order Aberration Before and After Femtosecond Laser-Assisted in Situ Keratomileusis Using An Aspheric Ablation Profile
- ClinicalTrials.gov ID
- NCT04966806
- Acronym / sponsor ID
- PSYoussef
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 10 Jul 2021 (estimated)
- Primary completion
- 15 Oct 2021 (estimated)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 19 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laser-assisted in situ keratomileusis (LASIK) is the most frequently performed refractive surgery procedure for the correction of myopia, hyperopia, and astigmatism.
There is a continuous upgrade and development in LVC surgeries correlated with the evolution of new machines and enhancement of the ablation profiles. One of the main undesirable effects of corneal refractive surgeries using conventional ablation profiles is the increase in HOAs which is associated with haloes, glare, ghost images, starburst patterns and monocular diplopia, especially in low lighting conditions and during night driving.
Over the years many ablation profiles have been developed such as wavefront-guided, wavefront optimized, topography guided, Q- Value based and aspheric ablation profiles. These profiles aim to abolish LOAs and to prevent induction or increase of pre-existing HOAs aiming to improve the quality of vision experienced post-operative.
In spite of the vast body of research in this area, there remains a gap in the literature investigating higher-order aberrations' components in-depth. Therefore, this study aims to investigate the contribution of spherical aberration and coma to the total higher order aberration before and after femtosecond assisted laser in situ keratomileusis using an aspheric ablation profile.
This current study is a Descriptive analytical study that was conducted on 34 eyes of 17 patients who underwent corneal refractive surgery.
The results were analyzed to compare the effect of FS-LASIK surgery on corneal coma and SA, and the contribution of each of them on total ocular HOAs preoperative and post-operative.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Percentage of Coma and SA to Total ocular HOA | Other | Procedure: LASIK refractive surgery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: between 18 years and 45 years
- Myopes from -1.50 D to -8.00 D
- Astigmatism less than -4.00 D
- Normal Corneal Tomography with a Belin Ambrosio big D value of less than 1.6
Key exclusion criteria (4 listed)
- Unstable refraction for 1 year
- Corneal thickness less than 500 microns
- Expected Post Lasik Residual Stromal bed less than 300 microns
- All patients with post operative complications as epithelial overgrowth or decentered ablation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LASIK refractive surgerylaser vision correction for myopic eyes | Procedure or surgery | Percentage of Coma and SA to Total ocular HOA |
Primary outcome
Change in percentage of contribution of coma and spherical aberration from total ocular HOA before and after FS-LASIK.
Time frame: 6 months
Measuring unit for coma and spherical aberrations and total ocular HOA is equivalent Diopters. The contribution of coma and spherical aberrations to total ocular HOA will be measured as a percentage.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LASIK refractive surgery in people with FS-LASIK Surgery Effect on Higher Order Aberrations, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percentage of contribution of coma and spherical aberration from total ocular HOA before and after FS-LASIK. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021.